Simulated bone or tissue manipulation

ABSTRACT

The present invention is directed to a system and method for performing tissue, preferably bone tissue manipulation. The system and method may include implanting markers on opposite sides of a bone, fractured bone or tissue to facilitate bone or tissue manipulation, preferably in-situ closed fracture reduction. The markers are preferably configured to be detected by one or more devices, such as, for example, a detection device so that the detection device can determine the relative relationship of the markers. The markers may also be capable of transmitting and receiving signals. An image may be captured of the bone or tissue and the attached markers. From the captured image, the orientation of each marker relative to the bone fragment may be determined. Next, the captured image may be manipulated in a virtual or simulated environment until a desired restored orientation has been achieved. The orientation of the markers in the desired restored orientation may then be determined. The desired relationship between markers may then be programmed into, for example, the detection device. Next, actual physical reduction and/or manipulation of the bone may begin. During the manipulation procedure, the orientation of the markers may be continuously monitored and when the markers substantially align with the virtual or simulated orientation of the markers in the desired restored orientation, an indicator signal is transmitted.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. provisional patent applicationSer. No. 60/837,193, filed Aug. 11, 2006, the contents of which ishereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

The invention relates generally to orthopedics. More specifically, theinvention relates to a system and method of performing bone or tissuemanipulation.

BACKGROUND OF THE INVENTION

During an operation for bone fracture fixation, proper reduction (e.g.alignment) of the fracture prior to placement of any fixation devicesand/or implants affects restoration of the patient's biomechanicalfunction. Fracture reduction may be the most difficult part of the bonefracture fixation procedure. In addition, as techniques for minimallyinvasive fracture repair have developed, more surgeons are performingclosed fracture reduction (e.g. a procedure for setting a fractured bonewithout making a skin incision at the fracture site).

Surgeons often use visual information to determine the adequacy offracture reduction. For instance, in limb fracture correction, surgeonsmay compare the treated limb's length and rotation to the correspondinguninjured limb, the goal being symmetry and balance. Surgeons may alsouse x-ray data, particularly intra-operative fluoroscopy, to monitor theposition and/or orientation of the bone fragments and determine whenadequate reduction is achieved.

Computer navigation systems may also be used to aid surgeons in fracturereduction and fracture fixation. Using infrared optical systems andinstruments with reflective tracking balls or active infraredlight-emitting markers, surgeons can monitor the position and/ororientation of fixation devices and/or implants within the bone and alsomonitor the position and/or orientation of the bone fragments relativeto one another. Other navigation systems utilize electromagnetic fieldsto accomplish similar objectives. Drawbacks associated with thesetechnologies are the expense and cumbersome nature of the equipmentrequired to use them. Their use in the operating room is particularlychallenging because the operating room is generally a very restrictiveenvironment. Operating rooms often lack the necessary space for largeequipment and working around the sterile field poses many constraints onfreedom to use equipment. For example, with optical navigation systems,the equipment in the operating room is generally large and imposing, andthe surgical staff must be mindful of standing in the way of theline-of-sight of the equipment for it to properly function.

Thus, there exists a need for a surgical system and/or method whichimproves the accuracy of bone or tissue manipulation or bone fracturereduction and enables the surgeon and/or doctor to verify that thedesired pre-operative surgical plan for the patient is being achieved.

SUMMARY OF THE INVENTION

The present invention is directed to a system and method for performingtissue, and more specifically bone, manipulation. The system and methodseeks to improve the accuracy of bone or tissue manipulation and enablesurgeons and/or doctors to verify that the desired pre-operative planfor the patient is being achieved.

In one exemplary embodiment, the method of performing bone or tissuemanipulation may include implanting at least one marker on oppositesides of one or more bone, tissue or bone fragments, wherein theposition of the markers is preferably capable of being determined. Next,the method may include capturing an image of the bone, tissue or bonefragments with the markers attached. The surgeon and/or doctor may thenmanipulate the image of the bone, tissue or bone fragments in a virtualor simulated environment to a desired restored orientation. Next, theorientation of the markers in the desired restored orientation ispreferably determined. The surgeon and/or doctor may then manipulate thebone, tissue or bone fragments until an indicator signal is generatedindicating that the desired restored orientation has been substantiallyachieved.

In another exemplary embodiment, the method of performing bone or tissuemanipulation may include implanting at least one marker on oppositesides of one or more bone, tissue or bone fragments, wherein theposition of the markers is preferably capable of being determined. Next,the method may include capturing an image of the bone, tissue or bonefragments with the markers attached. The surgeon and/or doctor may thenmanipulate the image of the bone, tissue or bone fragments in a virtualor simulated environment to a desired restored orientation. Next, theorientation of the markers in the desired restored orientation may bedetermined. The method may also include providing an indicator signalwhen the bone, tissue or bone fragments have been manipulated such thatthe position of the markers on the bone, tissue or bone fragmentssubstantially corresponds to or matches the position of the markers inthe desired restored orientation.

In yet another exemplary embodiment, the method of performing bone ortissue manipulation may include implanting and associating at least onemarker on opposite sides of a bone, tissue or bone fragments, whereinthe markers are capable of communicating a signal with an externaldevice, the signal containing information as to the markers orientationand/or position. The method may also include acquiring an image of thebone, tissue or bone fragments; manipulating the image of the bone,tissue or bone fragments in a virtual or simulated environment until thebone, tissue or bone fragments have achieved a desired restoredorientation; determining the orientation of the markers in the desiredrestored orientation; programming the external device with theorientation of the markers in the desired restored orientation so thatthe external device generates an indicator signal when the externaldevice determines that the orientation of the implanted markerssubstantially corresponds with the position of the imaged markers in thedesired restored orientation; and manipulating the bone, tissue or bonefragments until the indicator signal is generated.

The markers may be passive markers. Alternatively, the markers may becapable of one or more of the following: (i) transmitting a signal to anexternal device; (ii) receiving a signal from an external device; (iii)both transmitting and receiving a signal; and/or (iv) communicating withone another in order to determine their relative orientation. Themarkers may also be programmable so that the implanted markers can beprogrammed before manipulating the bone, tissue or bone fragments, themakers may be programmed with the desired restored orientation.

The method for performing bone or tissue manipulation may alsoincorporate an external device, the external device being capable of oneor more of the following: (i) detecting the positions of the markers;(ii) monitoring the positions of the markers; (iii) both detecting andmonitoring the positions of the markers; (iv) communicating with themarkers; (v) being programmed with the orientation and/or position ofthe markers and/or (vi) generating an indicator signal upon determiningthat the position of the implanted markers have been manipulated so thatthey substantially correspond with the position of the virtual markersin the desired restored orientation.

The method of performing bone or tissue may further include implantingat least one fracture fixation device to the bone, tissue or bonefragments.

In use, preferably one or more of the steps of implanting the markers,capturing the image of the bone fragments, manipulating the image of thebone fragments, determining the orientation of the markers, and/ormanipulating the bone, tissue or bone fragments occurs outside of theoperating room setting.

In yet another exemplary embodiment, the system and method of performingbone or tissue manipulation may include implanting markers on oppositesides of a bone, tissue or bone fragments. The position of the markersare preferably capable of being detected by an external device so thatthe external device can determine the relative relationship of themarkers. The markers may be passive or active. If active, the markersmay be configured to transmit a signal to and optionally receive asignal from the external device. The markers may also be capable oftransmitting and optionally receiving signals with respect to oneanother. The method of performing bone or tissue manipulation may alsoinclude capturing an image of the bone, tissue or bone fragments andoptionally the attached markers. From the captured image, the positionand/or orientation of each marker relative to the bone, tissue or bonefragments may be determined. Next, the captured image may be manipulatedin a virtual or simulated environment until a desired restoredorientation has been achieved. The position and/or orientation of themarkers in the desired restored orientation may then be determinedand/or calculated.

The desired relationship between the markers may preferably beprogrammed into the markers and/or the external device. Next, physicalmanipulation of the bone, tissue or bone fragments may begin. Duringphysical manipulation, the position and/or orientation of the markersmay be monitored, preferably continuously, so that when the markerssubstantially align with the computer generated position and/ororientation of the markers in the desired restored orientation, anindicator signal is transmitted.

BRIEF DESCRIPTION OF THE DRAWINGS

The system is explained in even greater detail in the followingexemplary drawings. The drawings are merely exemplary to illustrate thestructure of preferred devices and certain features that may be usedsingularly or in combination with other features. The invention shouldnot be limited to the embodiments shown.

FIG. 1 illustrates a fractured bone to which markers have been attached,FIG. 1 further illustrates a two-way line of communication between themarkers;

FIG. 2 illustrates a flow chart describing an exemplary method forperforming bone or tissue manipulation;

FIG. 3 illustrates an exemplary method for performing bone or tissuemanipulation;

FIG. 4 illustrates two ways in which data may be generated in accordancewith the exemplary embodiment of FIG. 3;

FIG. 5 illustrates three ways in which the acquired data may be used inaccordance with the exemplary embodiment of FIG. 3;

FIG. 6 illustrates an exemplary method for performing bone or tissuemanipulation;

FIG. 7 further illustrates the exemplary method for performing bone ortissue manipulation of FIG. 6;

FIG. 8 further illustrates the exemplary method for performing bone ortissue manipulation of FIG. 6;

FIG. 9 further illustrates the exemplary method for performing bone ortissue manipulation of FIG. 6;

FIG. 10 further illustrates the exemplary method for performing bone ortissue manipulation of FIG. 6;

FIG. 11 further illustrates the exemplary method for performing bone ortissue manipulation of FIG. 6;

FIG. 12 illustrates the exemplary method for performing bone or tissuemanipulation of FIG. 6;

FIG. 13 illustrates a top and cross-sectional view of a signal receivingand/or transmitting platform;

FIG. 14 illustrates one exemplary method for transmitting the signal inaccordance with one exemplary embodiment of the method for performingbone or tissue manipulation;

FIG. 15 illustrates another exemplary method for transmitting the signalin accordance with another exemplary embodiment of the method forperforming bone or tissue manipulation;

FIG. 16 illustrates another exemplary method for transmitting the signalin accordance with another exemplary embodiment of the method forperforming bone or tissue manipulation;

FIG. 17 illustrates the incorporation of markers onto intra-operativesurgical instruments and fixation devices/implants according to anotheraspect of the exemplary embodiment of the method for performing bone ortissue manipulation;

FIG. 18 illustrates exemplary marker placements;

FIG. 19 illustrates exemplary marker placements;

FIG. 20 illustrates exemplary marker placements;

FIG. 21 illustrates the use of a portable data storage according to oneaspect of the exemplary embodiment of the method for performing bone ortissue manipulation; and

FIG. 22 illustrates the use of a hospital network according to anotheraspect of the exemplary embodiment of the method for performing bone ortissue manipulation.

DETAILED DESCRIPTION

Certain exemplary embodiments of the invention will now be describedwith reference to the drawings. In general, such embodiments relate toan apparatus, system and/or method for performing and optionallyverifying tissue, preferably bone, manipulation.

While the system and method of the present invention may be generallydescribed as, generally shown as and may generally be used in connectionwith fracture fixation, it should be understood that the system and/ormethod for performing bone or tissue manipulation is not limited in useto repairing bone fractures. Rather, the system and/or method forperforming bone or tissue manipulation may be used for manipulatingbone, manipulating tissue, manipulating bone fragments caused by, forexample, injury, deformation, degeneration, disease, etc. The systemand/or method for performing bone or tissue manipulation is not limitedto any particular type of fracture and, in fact, may be used even whereno fracture exists. The system and/or method for bone or tissuemanipulation only requires desired relative movement or manipulation ofbone, bone fragments, tissue, etc.

The system and/or method for performing bone or tissue manipulation maybe used in connection with bone markers. The system and/or method, byway of non-limiting example, may include implanting markers on oppositesides of a fractured bone. The implantation of the markers may be usedto facilitate in-situ closed fracture reduction. The system and/ormethod preferably enables one or more steps of the fracture reductionprocedure to occur substantially outside of the operating room setting.For example, preferably one or more of the steps of implanting themarkers, capturing the image of the bone fragments, manipulating theimage of the bone fragments, determining the orientation of the markers,programming the implanted markers, and/or manipulating the fracture bonemay occur outside of the operating room setting.

The markers may be passive (e.g., incapable of transmitting and/orreceiving a signal, for example, a radiopaque marker) or active (e.g. atransmitter capable of sending a signal). The markers may incorporateelectronic transmitters or receivers. The markers may incorporate bothreceivers and transmitters so that the markers can receive and transmita signal. The markers may be capable of receiving and sending signalswith an external device, such as, for example, a detection device, whichwill be described in greater detail below. Alternatively and/or inaddition, the markers may be capable of receiving and sending signalswith respect to one another in order to determine their relativeorientation. The signal preferably contains information as to theposition and/or orientation (collectively referred to herein asorientation) of the markers and hence the attached bone fragments.Alternatively, one of the markers may incorporate a transmitter whilethe other marker may incorporate a receiver. For example, if during asurgical procedure, it is desired for one bone fragment to remainrelatively stationary and for the other bone fragment to be manipulated,it may not be necessary for both markers be configured to receive andtransmit signals.

Moreover, the markers may be nonprogrammable and the detection device,which will be described in greater detail below, may be programmablesuch that the detection device is capable of determining when themarkers have arrived at the desired restored orientation with respect tothe planned fracture reduction, which will also be described in greaterdetail below. Alternatively and/or in addition, one of the markers maybe programmable while the other marker(s) may be nonprogrammable, whilein an alternate embodiment, both or all of the markers may beprogrammable so that the markers themselves are capable of determiningwhen they have arrived at the desired restored orientation. In addition,one of the markers may function in a master mode while the othermarker(s) may function in a slave mode.

The markers may also be anchored to the bone by any means known in theart including but not limited to pins, nails, barbs, threads, screws,adhesive, etc. The markers are preferably capable of being fixedlysecured with respect to the bone to which they are being attached sothat the orientation of the markers with respect to the bone is fixed.The markers preferably are small enough so that they may be insertedinto the patient's body and attached to a patient's bone through a smallincision, such as for example a stab incision. Alternatively, themarkers may be inserted into the patient's body by any means includingbut not limited to, an open incision, an injection, etc.

A function of the markers is that the position of the marker should bedetectable. It should be understood that the system and/or method forperforming bone or tissue manipulation is not limited in use to anyparticular type of marker.

In use, the position of the markers may be detected by any means knownin the art including but not limited to the detection device. Thedetection device may detect the position of the markers by any meansknown in the art including, but not limited to, visual, sound, radiowaves, infrared, electromagnetic, electrical, x-rays, reflective,ultrasound, mechanical waves, GPS systems or chips, magnetic,transducer, etc. In addition, as previously mentioned, the markers maybe capable of sending a signal to the detection device and the detectiondevice may determine the relative relationship of the markers.

The detection device may also be capable of generating and transmittingan indicator signal when the desired restored orientation of thefractured bone has been achieved, as will be described in greater detailbelow. Alternatively, an indicator device which may be a separate anddistinct device from the detection device may generate and transmit anindicator signal when the desired restored orientation of the tissue,bone or bone fragments has been achieved.

The detection device can be any known device capable of detecting theposition of the markers. For example, the detection device may be acomputer console, x-ray machine, computed tomography (CT) scan, areceiver specifically designed for such purpose, etc. It should beunderstood that the system and/or method for performing bone or tissuemanipulation is not limited in use to any particular type of detectiondevice.

Referring to FIGS. 1 and 2, an exemplary system and/or method forperforming bone or tissue manipulation will be described in connectionwith a mid-shaft fracture of a long bone 100. As shown, the surgeonand/or doctor preferably places a single marker 102, 104 on each side ofthe fracture 106. Although more than one marker may be placed on eitherside of the fracture if desired and/or required. The markers 102, 104are preferably positioned in locations that will not interfere with anysurgical instruments that may be required to complete the fracturereduction. Moreover, the markers 102, 104 are preferably positioned inlocations that will not interfere with placement of any fixation devicesand/or implants that may be implanted. More preferably, the markers 102,104 are preferably secured to the fractured bone on either side of thefracture 106 as close as possible to the bone ends opposite the bonefracture 106. The placement of the markers 102, 104 preferably occursprior to the fracture fixation surgery so that the placement of themarkers 102, 104 may occur outside of the operating room, in advance ofthe surgeon's pre-operative planning. For example, a radiologist mayimplant the markers 102, 104 prior to image acquisition.

Next, a scan may be taken of the fractured bone 100 and markers 102,106. The scan may be any scan known in the art including but not limitedto a computed tomography (CT) scan, a three dimensional (3D) imagecapture, a set of at least two non-parallel two dimensional (2D) images,which allows for 3D reconstruction of the image data, etc.

Next, using the captured image, the orientation of each marker 102, 104relative to the bone fragment to which it is attached may be determined.The markers 102, 104 may essentially serve as a surgeon-appliedlandmark. As part of the pre-operative planning, the surgeon canmanipulate the captured image or software-generated model, preferably 3Dsolid model, of the bone fragments in a simulated or virtual environmentuntil a desired restored orientation has been achieved.

Many navigational system manufacturers produce and/or sell softwarecapable of the desired functionality. For example, software currentlyexists for navigating IM nailing. Moreover, off-the-shelf softwarepackages containing similar functionality include BrainLAB TraumaModule, Sekvenca.com and Singapore General Hospital Project. In analternate exemplary embodiment, instead of working with softwaregenerated 3D solid models, actual patient data or an actual dummy modelprepared using the patient's data may be utilized. It should beunderstood that the system and/or method for performing bone or tissuemanipulation is not limited in use to any particular type ofnavigational device and/or software.

Once the desired restored orientation has been achieved by manipulatingthe simulated or virtual image, the orientation of the markers 102, 104in their new, desired restored orientation may be determined and/orcalculated. The desired restored orientation of the markers 102, 104 maythen be programmed into the detection device. Alternatively and/or inaddition, if the markers 102, 104 are capable of receiving andtransmitting a signal, the desired restored orientation of the markers102, 104 may be programmed into the markers 102, 104 themselves.

Once the desired restored orientation of the markers 102, 104 has beenprogrammed into, for example, the detection device, actual physicalreduction of the fracture may begin. The actual physical reduction ofthe fracture may be performed by any means including but not limited tosurgeon applied distractive forces via a reduction frame, fracturetable, etc. During actual physical reduction of the fracture, theorientation of the markers 102, 104 may be monitored, preferablycontinuously, by, for example, the detection device. Alternativelyand/or in addition, the markers 102, 104 may signal to one another theirrelative orientation. The markers 102, 104 may communicate with oneanother and/or with the detection device by any means including, but notlimited to, via hard wire, wirelessly such as by radio frequency orother electromagnetic signals, via acoustic signals, etc.

Once the detection device and/or the markers 102, 104 have detected thatthe orientation of the markers 102, 104 substantially corresponds withor substantially matches, within some acceptable tolerance, theorientation of the markers in the desired restored orientation of theimage from the virtual or simulated environment, an indicator signal ispreferably generated and transmitted to indicate that the desiredrestored orientation has been achieved. Once the indicator signal hasbeen generated, the fixation procedure may proceed as is normallyperformed in order to fix the relative orientation of the bonefragments. The orientation of the bone fragments may be fixed by anymeans known in the art including, but not limited to, a plate and screwconstruct, a rod and screw construct, external fixator, IM rod, etc.

The indicator signal may be any indicator signal known in the artincluding, but not limited to, visual cues such as, for example, colorchanges or alignment of articulating lines on a computer screen, sounds,flashes of light, etc. The indicator signal may be generated by thedetection device. Alternatively, the indicator signal may be generatedby an indicator device specifically designed for such purpose.Alternatively, the indicator signal may be generated by one or more ofthe markers 102, 104, a marker transponder or receiver (which will bedescribed in greater detail below), etc.

Upon completion of the fracture reduction procedure, the markers 102,104 may be removed from the patient's body. Alternatively, the markers102, 104 may be made from a resorbable or partially resorbable material.As will be generally understood by one of ordinary skill in the art, theuse of resorbable markers eliminates the need for subsequent surgicalremoval of the markers 102, 104.

Referring to FIG. 3, an exemplary method for performing bone or tissuemanipulation may include implanting one or more markers 102, 104 oneither side of a fracture 106 of a long bone 100. Next, an image of thefractured bone 100 and markers 102, 104 may be taken using, for example,an x-ray machine 110 or any other suitable imaging device. Imaging datamay be provided via a marker transponder or receiver (e.g., a signalreceiving and/or transmitting unit) 108 so that the marker transponderor receiver 108 can transmit the data to the detection device 114, whichmay be optionally connected to another marker transponder or receiver108′ so that the detection device 114 can transmit and/or receive data.Alternatively, the detection device 114 may integrally incorporate themarker transponder or receiver 108′. The image of the fractured bone 100and bone markers 102, 104 may be displayed on a monitor 112. Inaddition, the image of the fractured bone 100 may be sent via a markertransponder or receiver 108″ to an intra-operative bone and markermonitor 113 so that the image may be viewed in the operating room. Asshown, the intra-operative bone and marker monitor 113 may be connectedto a marker transponder or receiver 108″ so that the intra-operativebone and marker monitor 113 can receive and/or transmit data.Alternatively, the intra-operative bone and marker monitor 113 mayintegrally incorporate the intra-operative bone and marker monitor 113″.As described, the marker transponder or receiver may enable the data tobe sent wirelessly. Alternatively, the data may be sent via wire leads118 or any other methods.

As shown in FIG. 4 and as previously mentioned, data relating to therelative orientation of the markers 102, 104, and hence to the fracturedbone fragments, may be generated primarily for two reasons. First, datarelating to the relative orientation of the markers 102, 104 may begenerated in order to acquire images of the fractured bone 100 and todefine the orientation of the markers 102, 104 relative to the actualimage generated by the x-ray or other similar machine 110. Second, datarelating to the relative orientation of the markers 102, 104 may begenerated to define the desired orientation of the markers 102, 104relative to the newly edited image.

Moreover, as best shown in FIG. 5, the data acquired, as describedabove, may be used primarily for three reasons. First, the data acquiredmay be used to intra-operatively monitor and optionally display theattached bone fragments in order to show the doctor and/or surgeon theorientation of the bone fragments during re-alignment. Second, the dataacquired may be used to intra-operatively monitor and optionally displaythe attached bone fragments so that the doctor and/or surgeon canmanipulate the bone fragments aided by the system. Third, the dataacquired may be used to intra-operatively monitor and optionally displaythe attached bone fragments so that the doctor and/or surgeon cannavigate surgical instruments 200 and/or fixation devices/implants (aswill be described in greater detail below).

As shown in FIGS. 6-12, the system or method for performing bone ortissue manipulation may include implantation of at least one marker 102,104 onto the fractured bone 100 on either side of the fracture 106. Asbest shown in FIG. 18 and as previously mentioned, the markers 102, 104are preferably secured to the fractured bone on either side of thefracture as close as possible to the bone ends opposite the fracture106. Moreover, as shown, for complex fractures, a marker 102, 104 may beplaced only on the far ends of the fractured bone 100 being reduced.Alternatively, however, a marker 102, 104 may be installed on each ormost of the bone fragments.

Next, an image of the fractured bone 100 may be acquired using, forexample, an x-ray 110 or any other suitable imaging device such as butnot limited to 3D x-ray, a computed tomography (CT) scan, a magneticresonance imaging (MRI), an ultrasound, etc.

Once the image of the fractured bone 100 has been obtained, the imagemay be merged with the orientation data obtained from the markers 102,104 via, for example, the detection device 114. Preferably, the image ofthe fractured bone 100 may be overlapped and/or calibrated with theorientation data obtained by, for example, the detection device 114, sothat the orientation of each markers 102, 104 is accurately reflectedrelative to each other at the time the image was captured.

Next, the pre-operative fracture reduction of the image may bepreferably performed by the doctor and/or surgeon, aided by the image ofthe fractured bone displayed on, for example, a computer monitor 112,which may be based on the bone images and marker orientation. Thevirtual or simulated fracture reduction may be software based or anyother means. After the virtual or simulated fracture reduction iscompleted, the data regarding the desired orientation of the markers102, 104 may be stored in, for example, the detection device 114.Alternatively and/or in addition, the data regarding the desiredorientation of the markers 102, 104 may be stored in one or more markertransponder or receivers, the markers themselves, or any other storageunit known in the art, such as, for example, a portable data storageunit as shown in FIG. 21, a hospital network as shown in FIG. 22, etc.so that the data can be used as a reference for the actual physicalintra-operative fracture reduction. That is, for example, the detectiondevice 114 may be programmed with the desired restored orientation ofthe bone fragments. During intra-operative fracture reduction, and basedon the pre-operative virtual or simulated manipulation of the bonefragments, the system and method is preferably capable of automaticallyrecognizing the actual orientation of the markers 102, 104 as they arebeing manipulated so that, for example, the detection device 114 caninform the doctor and/or surgeon via an indicator signal when the bonefracture has been properly reduced to the desired restored orientation.Alternatively and/or in addition, as previously mentioned, the markertransponder or receiver and/or the markers themselves may be programmedwith the desired restored orientation of the bone fragments. Moreover,the marker transponder or receiver and/or the markers themselves may becapable of producing the indicator signal when the bone fracture hasbeen properly reduced to the desired restored orientation. Alternativelyand/or in addition, the method of performing bone or tissue manipulationmay include an indicator device for transmitting the indicator signal.

Moreover, during intra-operative fracture reduction, the manipulationand orientation of the markers and hence of the bone fragments, may becontinuously tracked and displayed in real time on a monitor 113 to aidthe doctor and/or surgeon in reducing the fracture to the appropriateorientation. Once the desired restored orientation has been achieved,fixation of the fractured bone may be completed and reconfirmationand/or monitoring of the fracture can be performed with the aid of theimage displayed on the monitor 113.

In addition to or alternatively from the detection device 114, as shownin FIG. 13, the system and method for performing and optionallyverifying bone or tissue manipulation may include a signal receivingand/or transmitting platform 144. The signal receiving and/ortransmitting platform 144 may be in the form of a table, a frame, aboard, a bed or any other support system that will accommodate thefractured bone 100 so that the markers 102, 104 can be monitored via thesignal receiving and/or transmitting platform 144. The signal receivingand/or transmitting platform 144 may include one or more sensors 140capable of detecting the orientation of the markers 102, 104.

As previously mentioned and as best shown in FIG. 14, the system andmethod for performing and optionally verifying bone or tissuemanipulation preferably detects and preferably transmits signalscontaining the data on the orientation of the markers 102, 104wirelessly 116. The wireless signal 116 may be received and/ortransmitted by the various marker transponder or receivers 108. Thewireless signal 116 may then be displayed on monitors 113.

Alternatively and/or in addition, as best shown in FIGS. 15 and 16, andas previously mentioned, the markers 102, 104 may be capable of bothtransmitting signals and/or receiving signals so that the markers 102,104 can directly exchange signals regarding their orientation withrespect to one another. The markers 102, 104 are also preferably capableof transmitting signals to one or more marker transponder or receivers108. The signals may then be transmitted to, for example, the detectiondevice, a display unit (e.g. a monitor), etc. The signals may then betransmitted by any means known in the art including by way of wires 118,wirelessly 116, etc. In the embodiment where the signals are transmittedvia a wire 118, the markers 102, 104 may include a wire that exits thepatient through the stab incisions and which connects to, for example,the detection device (e.g. computer console), enabling bothcommunication between the markers 102, 104, as well as communicationbetween the markers 102, 104 and the detection device used to alert thesurgeon that a desired restored orientation has been achieved.

In addition, the marker technology may also be incorporated intosurgical instruments and/or fixation devices/implants to help facilitateaccurate placement of the surgical instruments and/or fixationdevices/implants. As shown in FIG. 17, in addition to fracturereduction, surgical instruments 200 and/or surgical implants 208 can beequipped with one or more markers 102. The surgical instruments 200and/or fixation devices/implants 208 may then be navigated based onpre-operative determination of the desired restored orientation of thebone fragments. Similar to the markers used in connection with thereduction procedure, the surgical instrument and/or fixationdevice/implant marker can be calibrated and predefined to a specificinstrument or implant.

Although the system and method for performing and optionally verifyingbone or tissue manipulation has been described and may generally be usedfor fixation of the long bones, those skilled in the art will appreciatethat the markers and system may be used for fixation of other parts ofthe body such as, for example, in the spine (as best shown in FIG. 19)for correction or movement of vertebra, for cranio-facial and mandiblereconstruction (as best shown in FIG. 20), joints, bones in the hand,face, feet, extremities, etc. The system and method for performing andverifying fracture reduction may also be useful in complex fractures,such as for example, those shown in FIG. 18.

In addition, it should be understood that the embodiments describedherein include not only pairs of markers, but also a system or aplurality of markers. This may be particularly useful for situationswhere multiple fragments are to be brought together or in the spine,where correction involves multiple, distinct vertebrae that requireindividual tracking. The system may allow for selective communicationbetween the markers via channels or distinct frequencies.

It is foreseeable that the markers described herein can have manyapplications. For example, the markers may be applied on a short-termbasis such as, for example, for no more than one or two days.Alternatively, the markers may be implanted for a long-term period. Inthis manner, the markers may be useful in monitoring the progress ofdeformity correction procedures where distraction osteogenesis takesplace over a period of weeks or months. It is also conceivable that themarkers could be used to provide biomechanical data related to thesuccess of fracture healing. The markers could be used to develop abetter understanding of the strain seen by a bone.

Alternatively, surgeons may prefer to use the markers in a more“on-the-fly” manner, without pre-op planning, or reliance on 3D imaging.In this case, the markers may be used to limit the patient's exposure toradiation by reducing the use of intra-operative fluoroscopy. Thesurgeon may implant the markers as described above and may take aperpendicular pair, for example an anterior/posterior view and a lateralview, of 2D images inclusive of the markers. The surgeon then “tags” orregisters each marker to the 2D image of the bone fragment to which itis anchored, designating one bone fragment in the image to bestationary. As the reduction maneuver is being performed, the mobile 2Dbone fragment representation moves on-screen in both views, tracking themotion that the markers communicate to the external signaling devicesuch that the surgeon has an on-screen estimation of what the actualimages would look like if they were taken live. In such an embodiment,the limb preferably is maintained absolutely stationary during imagingand tagging prior to any reduction maneuver. Further, in such anembodiment the imaging and tagging procedure may be repeatedmid-reduction to get a refreshed true image if there is concern that theestimated image is inaccurate due to inadvertent motion during thecapture and tagging procedure, or due to a rotational component of thereduction maneuver.

While the foregoing description and drawings represent the preferredembodiments of the present invention, it will be understood that variousadditions, modifications, combinations and/or substitutions may be madetherein without departing from the spirit and scope of the presentinvention as defined in the accompanying claims. In particular, it willbe clear to those skilled in the art that the present invention may beembodied in other specific forms, structures, arrangements, proportions,and with other elements, materials, and components, without departingfrom the spirit or essential characteristics thereof. One skilled in theart will appreciate that the invention may be used with manymodifications of structure, arrangement, proportions, materials, andcomponents and otherwise, used in the practice of the invention, whichare particularly adapted to specific environments and operativerequirements without departing from the principles of the presentinvention. In addition, features described herein may be used singularlyor in combination with other features. The presently disclosedembodiments are therefore to be considered in all respects asillustrative and not restrictive, the scope of the invention beingindicated by the appended claims, and not limited to the foregoingdescription.

1. A method of performing bone or tissue manipulation comprising thesteps of: implanting at least one marker on opposite sides of one ormore bone, tissue or bone fragments, wherein the position of the markersis capable of being determined; capturing an image of the bone, tissueor bone fragments with the markers attached; manipulating the image ofthe bone, tissue or bone fragments in a virtual or simulated environmentto a desired restored orientation; determining the orientation of themarkers in the desired restored orientation; and manipulating the bone,tissue or bone fragments until an indicator signal is generatedindicating that the desired restored orientation has been substantiallyachieved.
 2. The method according to claim 1, wherein the markers arecapable of transmitting a signal to an external device, the signalcontaining information as to the markers orientation.
 3. The methodaccording to claim 1, wherein the markers are capable of receiving asignal from an external device, the signal containing information as tothe markers orientation.
 4. The method according to claim 1, wherein themarkers are capable of both transmitting to and receiving from anexternal device a signal, the signal containing information as to themarkers orientation.
 5. The method according to claim 4, furthercomprising the step of programming the implanted markers beforemanipulating the bone, tissue or bone fragments, the makers beingprogrammed with the desired restored orientation and instructing themarkers to communicate with an external device, the external devicebeing capable of generating the indicator signal upon the markers beingmanipulated into the desired restored orientation.
 6. The methodaccording to claim 1, wherein the markers are passive markers.
 7. Themethod according to claim 1, wherein the markers are capable ofcommunicating with one another in order to determine their relativeorientation.
 8. The method according to claim 7, wherein thecommunication during the procedure between the markers is continuouslyperformed.
 9. The method according to claim 1, wherein the position ofthe markers is monitored by a detection device.
 10. The method accordingto claim 9, wherein the detection device is capable of determining whenthe markers have arrived at the desired restored orientation
 11. Themethod according to claim 9, wherein the detection device is capable oftransmitting the indicator signal.
 12. The method according to claim 1,further comprising the step of implanting at least one fracture fixationdevice to the bone, tissue or bone fragments after the desired restoredorientation has been achieved.
 13. The method according to claim 1,wherein the indicator signal is auditory.
 14. The method according toclaim 1, wherein the image is captured using a method selected from thegroup consisting of x-ray, three dimensional x-ray, computed tomography,magnetic resonance imaging and ultrasound.
 15. The method according toclaim 1, wherein the step of implanting the markers occurs outside of anoperating room setting.
 16. The method according to claim 15, whereinthe steps of capturing and manipulating the image of the bone, tissue orbone fragments occurs outside of the operating room setting.
 17. Themethod according to claim 16, wherein the step of determining theorientation of the markers relative to one another occurs outside of theoperating room setting.
 18. The method according to claim 17, whereinthe step of manipulating the bone, tissue or bone fragments until theindicator signal indicates that the desired restored orientation hasbeen substantially achieved occurs outside of the operating roomsetting.
 19. A method of performing bone or tissue manipulationcomprising the steps of: implanting at least one marker on oppositesides of one or more bone, tissue or bone fragments, wherein theposition of the markers is capable of being determined; capturing animage of the bone, tissue or bone fragments with the markers attached;manipulating the image of the bone, tissue or bone fragments in avirtual or simulated environment to a desired restored orientation;determining the orientation of the markers in the desired restoredorientation; and providing an indicator signal when the bone, tissue orbone fragments have been manipulated such that the position of themarkers on the bone, tissue or bone fragments substantially correspondsto the position of the markers in the desired restored orientation. 20.A method of performing bone or tissue manipulation comprising the stepsof: implanting and associating at least one marker on opposite sides ofa bone, tissue or bone fragments, wherein the markers are capable ofcommunicating a signal with an external device, the signal containinginformation as to the markers orientation; acquiring an image of thebone, tissue or bone fragments; manipulating the image of the bone,tissue or bone fragments in a virtual or simulated environment until thebone, tissue or bone fragments have achieved a desired restoredorientation; determining the orientation of the markers in the desiredrestored orientation; programming the external device with theorientation of the markers in the desired restored orientation andinstructing the external device to generate an indicator signal when theexternal device determines that the orientation of the implanted markerssubstantially corresponds with the position of the imaged markers in thedesired restored orientation; and manipulating the bone, tissue or bonefragments until the indicator signal is generated.